Healthy Volunteers (Cancer)HD-DNANCT07663994
Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort
A study testing 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL). in people with Healthy Volunteers (Cancer), run by Institut Claudius Regaud at 1 site in France.
Trial summary
Pilot, prospective, mono-center study conducted in a population of healthy participants (free of cancer) for the analytical validation of circulating DNA analysis methods. The participants are employees of the institution. Their recruitement is carried out via internal posting (intranet and bulletin boards). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (Cancer)
- What is being tested?
- 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2026to 17 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 Adult volunteer (≥ 18 y.o.)
- 2 Participant free of cancer
- 3 Participant belonging to the personnel of Oncopole Claudius Regaud (IUCT-O) institution
- 4 Participant affiliated to a Social Health Insurance in France
- 5 Participant who received clear and understandable information about the research
- 6 Participant who signed an informed consent form before inclusion into the study and before any study specific procedure
- 7 Participant who accepts a blood draw in the context of the research
- 8 Participant who agrees to be contacted in the event of an incidental finding of a potential genetic abnormality
Who cannot join
- 1 Participant presenting with an associated pathology potentially preventing the adequate conduct of the study procedure
- 2 Participant presenting with a contra-indication to blood draw
- 3 Participant who reports to the investigator team
- 4 Participant who has forfeited his/her freedom bu administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Trial locations and contacts
1 site in 1 country.
France1 site
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, 31059
About this study
Pilot, prospective, mono-center study conducted in a population of healthy participants (free of cancer) for the analytical validation of circulating DNA analysis methods. The participants are employees of the institution. Their recruitement is carried out via internal posting (intranet and bulletin boards). The study participation will be strictly voluntary and without consequences on the professional situation of the participants.
- Conditions
- Healthy Volunteers (Cancer)
- Being tested
- 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).
- Keywords
- circulating DNA, liquid biopsy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).Diagnostic test
The samples will be processed by the laboratory as follows: - extraction of circulating DNA; - NGS Sequencing on 2 gene-panels; - capillary electrophoresis; - digital PCR
| Study group | Role | What they receive |
|---|---|---|
| Blood draw for analysis | Experimental | Not described Receives: Diagnostic Test: 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel.
Ratio of number of participants without pathogenic mutation on the MSK-Access panel over the total number of participants
Measured: baseline
Secondary outcomes (4)
Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel
Ratio of number of participants without pathogenic mutation on the HRR-Liq panel over the total number of participants
Measured: baseline
Proportion of participants for wich no pathogenic mutation has been detected on by digital PCR
Ratio of number of participants without pathogenic mutation via digital PCR panel over the total number of participants
Measured: baseline
Analytical specificity of the estimation of the circulating tumoral fraction: Proportion of participants for which the circulating tumoral fraction is inferior to the detectability threshold
Ratio of the number of participants for which the circulating tumoral fraction is inferior to the detectability threshold over the total number of participants
Measured: baseline
Analytical specificity of the measurement of circulating DNA fragments' size via electrophoresis: Proportion of participants with an absence of DNA fragments of a size inferior to 150 pb
Ratio of the number of participants for which there are no DNA fragments of a sieze inferior to 150 pb over the total number of participants
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start16 Jul 2026
- Primary completion17 Aug 2026
- Study completion17 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Collaborators
- Sophia Genetics SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663994
- Sponsor's protocol ID
- 26 GENE 13
- Acronym
- HD-DNA
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Validation of Circulating DNA Analysis Methods: Creation of a Control Cohort
- ClinicalTrials.gov ID
- NCT07663994
- Acronym / sponsor ID
- HD-DNA / 26 GENE 13
- Conditions
- Healthy Volunteers (Cancer)
- Keywords
- circulating DNA, liquid biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Collaborators
- Sophia Genetics SAS
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 17 Aug 2026 (actual)
- Study completion
- 17 Aug 2026 (actual)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot, prospective, mono-center study conducted in a population of healthy participants (free of cancer) for the analytical validation of circulating DNA analysis methods. The participants are employees of the institution. Their recruitement is carried out via internal posting (intranet and bulletin boards). The study participation will be strictly voluntary and without consequences on the professional situation of the participants.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood draw for analysis | Experimental | Diagnostic Test: 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1 Adult volunteer (≥ 18 y.o.)
- 2 Participant free of cancer
- 3 Participant belonging to the personnel of Oncopole Claudius Regaud (IUCT-O) institution
- 4 Participant affiliated to a Social Health Insurance in France
- 5 Participant who received clear and understandable information about the research
Key exclusion criteria (4 listed)
- 1 Participant presenting with an associated pathology potentially preventing the adequate conduct of the study procedure
- 2 Participant presenting with a contra-indication to blood draw
- 3 Participant who reports to the investigator team
- 4 Participant who has forfeited his/her freedom bu administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL).The samples will be processed by the laboratory as follows: - extraction of circulating DNA; - NGS Sequencing on 2 gene-panels; - capillary electrophoresis; - digital PCR | Diagnostic test | Blood draw for analysis |
Primary outcome
Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel.
Time frame: baseline
Ratio of number of participants without pathogenic mutation on the MSK-Access panel over the total number of participants
4 secondary outcomes
Proportion of participants for wich no pathogenic mutation has been detected on the HRR-Liq panel
Time frame: baseline
Proportion of participants for wich no pathogenic mutation has been detected on by digital PCR
Time frame: baseline
Analytical specificity of the estimation of the circulating tumoral fraction: Proportion of participants for which the circulating tumoral fraction is inferior to the detectability threshold
Time frame: baseline
Analytical specificity of the measurement of circulating DNA fragments' size via electrophoresis: Proportion of participants with an absence of DNA fragments of a size inferior to 150 pb
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
Related trials for Healthy Volunteers (Cancer)
RecruitingPhase 1
A Study of [18F]LY4214835 in Healthy Volunteers and Participants With Cancer
Neoplasms, Healthy
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Enrolling by invitationObservational study
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
Neoplasms, Hematologic Neoplasms
RecruitingObservational study
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
Dermatologic Conditions, Healthy Volunteers
RecruitingObservational study
Tissue Repository: CTCL Collection Protocol
Lymphoma, T-Cell, Cutaneous, Lymphomatoid Papulosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1 single blood draw after in the inclusion of the participant in the study (Up to 30 mL). in people with Healthy Volunteers (Cancer), run by Institut Claudius Regaud at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants for which no pathogenic mutation has been detected on the MSK-Access panel. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.